“Foods with Function Claims”

System of “Foods with Function Claims” ……… Questions??

Who established this system and when ?

This health food labeling system was established by the Consumer Affairs Agency and came into effect on April 1st, 2015.

What is the system of Foods with Function Claims ? (FFC)

This is a new system of labeling the function claims of food in addition to the current Foods for Specified Health Uses (FOSHU, or Tokuho) and Foods with Nutrient Function Claims (FNFC).

FFC have the following characteristics:

1. Allows labeling of the function of a food ingredient e.g. “helps maintain good GI condition,”, ” slows fat absorption.”. However, it is not allowed to use wording or expressions that reflect any subjective image of a drug treatment.

2. Indicated for all types of health foods including supplements, drinks, and fresh foods.

3. It is necessary to submit the following information package according to the guideline released by the Consumer Affairs Agency. It basically includes safety, manufacturing, and scientific information regarding the function (see the FFC guideline for further details).

4. Scientific information must include either 1) Reports of clinical trials of the final product (follow FOSHU guideline) or 2) Systematic review of the targeted food ingredient(s).

5. This is not an approval system like FOSHU. It is just required to submit (via e-submission) the above-mentioned information package.

6. Once the information package is submitted to the Consumer Affairs Agency and the Agency confirms that there are no errors, then the submitter is allowed to launch the product after 60 days.

7. The Consumer Affairs Agency does not evaluate the information package and submitter is responsible for all product/label information, the safety, product quality and health outcome.

What is the difference between FOSHU ?

Table – Comparison of two main food labeling system in Japan

Foods with Function Claims

Foods for Specified Health Uses (FOSHU)

Regulatory

Submit the required information package (no review and no approval by the Agency)

Approval by the Agency

Scientific Evidence

Clinical Trial or Systematic Review

Clinical Trial

Timeline

60 days after submission

Review period: >6 months*

Cost

Low (few million JPY*)

High (>20 million JPY*)

Responsibility

Submitter (Company)

Agency

Transparency

Information package disclosed to the public via an URL

Details not disclosed

*estimate

How has the FFC been doing so far ?

Since the launch of this system, more than 400 products including supplements, drinks, fruit and vegetables have already been listed (as of Aug 2016), and many more are expected.

The sales of FFC products last year was estimated as 30.3 billion JPY (approx. 297 million USD) and is expected to exceed 70 billion JPY (approx. 690 million USD) in 2016. A number of companies are already showing considerable sales growth and expansion of their manufacturing capacity

For more details or information regarding this system, please access the following URL:

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